NASDAQ: CRME TSX: COM
VANCOUVER, April 17, 2018 /CNW/ - Cardiome Pharma Corp.
(NASDAQ: CRME / TSX: COM), a revenue-generating, specialty
pharmaceutical company focused on commercializing hospital
drugs, today announced completion of enrollment for the Phase
4 SPECTRUM study evaluating Brinavess® (vernakalant
hydrochloride, IV), the Company's antiarrhythmic drug for the rapid
conversion of recent onset atrial fibrillation (AF), in the
post-authorization setting in the European Union (EU).
In this prospective and retrospective observational registry,
2,000 patients were enrolled and assessed to characterize normal
conditions of use, dosing and safety following administration of
Brinavess. The full clinical study report (CSR) will be
available during third quarter 2018 and Cardiome plans to publish
these data.
"Completion of enrollment in the SPECTRUM study is an important
event for Brinavess as this large clinical study fulfills our
clinical commitments in the EU and adds important data on the use
of Brinavess in the real-world setting," said Kiran Bhirangi, M.D.,
Cardiome's Vice President, Clinical Development and Medical
Affairs. "This observational registry is designed to provide
robust, supportive data on the safety and effectiveness of
Brinavess and how it is used in real-world clinical
practice. We believe Brinavess is an important treatment
alternative for patients with recent onset AF, particularly for
those who require pharmacologic cardioversion. Brinavess has been
demonstrated to rapidly induce cardioversion and it remains a
clinically proven option for physicians treating patients in the
acute hospital setting."
About Atrial Fibrillation
Atrial Fibrillation (also known as AFib or AF) is a
supraventricular tachyarrhythmia with uncoordinated atrial
activation resulting in ineffective atrial contraction and, if left
untreated, structural and/or electrophysiological atrial tissue
abnormalities.1 AF is a common cardiac rhythm
disturbance that increases in prevalence with advancing
age.1 According to the American Heart Association,
estimates of the prevalence of AF in the U.S. ranged from 2.7
million to 6.1 million in 2010, and is expected to rise to between
5.6 million to 12 million in 2030.2 There are two
strategies to manage AF, namely, rhythm- or rate-control. A
rhythm-control strategy may be used in patients who are severely
compromised, remain symptomatic despite adequate rate control, when
adequate rate control is difficult to achieve, when long term
rhythm control therapy is preferred, younger patient age, presence
of tachycardia-mediated cardiomyopathy, and first episode of
AF.1,3 Early intervention with a rhythm-control strategy
to prevent progression of AF may be particularly beneficial to the
AF patient.1
About BRINAVESS®
Brinavess® (vernakalant HCl, IV) is an antiarrhythmic
drug that acts preferentially in the atria by prolonging atrial
refractoriness and slowing impulse conduction in a rate-dependent
fashion. Brinavess is approved for marketing in Europe, Canada and several other countries worldwide.
In Europe, it is approved for the
rapid conversion of recent onset atrial fibrillation to sinus
rhythm in adults: 1) for non-surgery patients: atrial fibrillation
< 7 days duration; and 2) for post-cardiac surgery patients:
atrial fibrillation < 3 days duration. Vernakalant IV is not
approved for use in the United
States.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a revenue-generating, specialty
pharmaceutical company focused on providing innovative,
high-quality brands that meet the needs of acute care physicians
and patients. With a commercial presence and distribution network
covering over 60 countries worldwide, Cardiome develops, acquires
and commercializes brands for the in-hospital, acute care market
segment. The Company's portfolio of approved and marketed brands
includes: Xydalba™ (dalbavancin hydrochloride), for the
treatment of acute bacterial skin and skin structure infections
(ABSSSI); Zevtera®/Mabelio® (ceftobiprole
medocaril sodium), a cephalosporin antibiotic for the treatment of
community- and hospital-acquired pneumonia (CAP, HAP);
Brinavess® (vernakalant IV), for the rapid conversion of
recent onset atrial fibrillation to sinus rhythm;
Aggrastat® (tirofiban hydrochloride), for the reduction
of thrombotic cardiovascular events in patients with acute coronary
syndrome, and Esmocard® and Esmocard Lyo®
(esmolol hydrochloride), a short-acting beta-blocker used to
control rapid heart rate in a number of cardiovascular indications.
Cardiome's pipeline of product candidates includes
Trevyent®, a drug device combination that is designed to
deliver treprostinil, the world's leading treatment for pulmonary
arterial hypertension.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the
Toronto Stock Exchange (COM). For more information, please visit
our web site at www.cardiome.com.
References
- January CT et al. 2014 AHA/ACC /HRS guideline for the
management of patients with atrial fibrillation. J AM Coll Cardiol.
2014;34:e1-e76.
- Mozaffarian D et al. Heart Disease and Stroke Statistics-2016
Update: A Report From the American Heart Association. Circulation.
2016 Jan 26;133(4):e38-60.
- Camm AJ et al. Guidelines for the management of atrial
fibrillation, The Task Force for the Management of Atrial
Fibrillation of the European Society of Cardiology (ESC).
Eur Heart J. 2010;31:2369-2429.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking
statements within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995 or forward-looking information under
applicable Canadian securities legislation ("forward-looking
statements") that may not be based on historical fact, including
without limitation statements containing the words "believe",
"may", "plan", "will", "estimate", "continue", "anticipate",
"intend", "expect" and similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause the actual results, events or developments
to be materially different from any future results, events or
developments expressed or implied by such forward-looking
statements. A discussion of the risks and uncertainties facing
Cardiome are discussed in our most recent annual and quarterly
reports and detailed from time to time in our other filings with
the Securities and Exchange Commission ("SEC") available at
www.sec.gov and the Canadian securities regulatory authorities at
www.sedar.com. All of the risks and certainties disclosed in these
filings are hereby incorporated by reference in their entirety.
While Cardiome makes these forward-looking statements in good
faith, given these risks, uncertainties and factors, you are
cautioned not to place undue reliance on any forward-looking
statements made in this press release. All forward-looking
statements made herein are based on our current expectations and we
undertake no obligation to revise or update such forward-looking
statements to reflect subsequent events or circumstances, except as
required by law.
Cardiome® and the Cardiome Logo are the proprietary
trademarks of Cardiome Pharma Corp.
Aggrastat® and Brinavess® are trademarks
owned by Cardiome and its affiliates worldwide.
Xydalba® is a trademark of Durata Therapeutics Holding
C.V., and used under license.
Zevtera® and Mabelio® are trademarks owned by
Basilea Pharmaceutica International Ltd., and used under
license.
Esmocard® and Esmocard Lyo® are trademarks
owned by Orpha-Devel Handels und Vertriebs GmbH, and used under
license.
Trevyent® is a trademark of SteadyMed and used under
license.
All other trademarks are the property of their respective
owners.
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SOURCE Cardiome Pharma Corp.